Should We Still Be Using Trackers For Clinical Trial Management?
By Donatella Ballerini, TMF Consultant

Have you ever planned a complex trip? Not just a simple beach getaway or a weekend in the mountains but a multi-city adventure in an unfamiliar country — packed with landmarks to visit, accommodations to book, and must-try restaurants to experience. If you’re anything like me, you’ve probably created a travel spreadsheet, meticulously laying out your itinerary. Sound a bit obsessive? Maybe. But having that plan ensures I don’t waste time (which is always limited and precious), miss connections, or overlook something amazing.
Now, think of trackers and logs as the ultimate travel itinerary for your clinical trial. They help you stay on course, keeping track of critical milestones, regulatory deadlines, and essential data points, so you’re not scrambling to fix avoidable issues at the last minute. Sure, maintaining them might feel tedious at times, but the payoff is invaluable: they streamline your journey, minimize disruptions, and ensure nothing important falls through the cracks. In the same way that a good itinerary makes travel seamless, trackers and logs are what keep your trial running smoothly and successfully from start to finish.
In an epoch where AI is increasingly becoming part of our everyday life, in clinical research, despite the recent progress from a technology perspective, people still develop and use trackers and logs, the majority of them manually created and maintained. While these tools are indispensable, their current usage reveals significant challenges and opportunities for improvement. This article explores the present state of trackers and logs in clinical trials, highlights their benefits, addresses their shortcomings, and provides practical insights for optimizing their use, concluding with a vision for a digital future.
Commonly Used Trackers And Logs In Clinical Trials
- Clinical Regulatory Submission and Approval Tracker: This tracks the submission of clinical studies to competent authorities and IRB/IECs and documents their approval status across multiple countries, sites, and regulatory bodies, ensuring timely compliance. This tracker is supportive when the regulatory landscape is complex and regulations and submission processes change from country to country.
- Informed Consent Form (ICF) Log: This maintains records of participant consent forms, tracking version control, translation and back translation, regulatory submissions, dates of consent, and participant signatures to ensure ethical compliance. It helps to keep the study updated with the latest version submitted to be on track with the story of your clinical study.
- Monitoring Visit Log: This documents site visits by the CRA. It records details such as visit dates, type of visit (e.g., pre-study visit or closeout visit), visit confirmation letter, and follow-up letter. It helps to verify adherence to what is established in the monitoring plan.
- Protocol Deviation Log: This logs any deviations from the trial protocol, documenting the nature of the deviation, its impact, and corrective actions taken.
- Note to File (NTF) Log: This is a repository for all explanatory notes addressing issues or clarifications that arise during the study, helping to maintain transparency and audit readiness.
- Serious Adverse Event (SAE) Log: This records SAEs reported during the trial, ensuring timely reporting to regulators and ethics committees.
- Risk Log: This tracks potential risks to the trial, detailing mitigation strategies and monitoring their resolution. Risks are part of a clinical study. We can’t ignore them, but we can try to figure out any potential risks in a tracker/log so if they happen, they won't surprise us.
- Quality Issue Log: This records noncompliance or quality concerns, ensuring they are addressed promptly and appropriately. Issues happen, but a proactive approach makes the difference, and this is why trackers/logs can support identifying trends.
- Oversight Tracker: This monitors sponsor and CRO oversight activities, ensuring compliance with contractual and regulatory obligations. This tracker will help when the inspector asks, “How do you perform oversight?”.
- TMF Quality Check Tracker: This ensures the TMF is complete, accurate, and audit-ready. As per your study TMF plan and your company SOP, you have to perform TMF quality checks regularly (quarterly, monthly, etc.). A tracker will help you verify your adherence to the established frequency.
Challenges And Pain Points
While trackers and logs are invaluable, their current usage presents several hurdles:
- Manual processes: Many trackers and logs are still maintained in spreadsheets or paper formats, making them time-consuming, error-prone, and not aligned with data integrity principles.
- Version control issues: Logs like the ICF log and protocol deviation log often involve multiple updates, creating challenges in maintaining accurate version histories.
- Data silos: Different trackers and logs often operate in isolation, leading to fragmented data that is difficult to consolidate and analyze. When the source of information is more than one, it can be challenging to understand the full picture.
- Compliance burden: Ensuring that trackers and logs meet regulatory requirements, such as good documentation practice (GDP), adds significant administrative workload. Does a tracker require a signature to become official? Does it have to be part of an SOP or WI (work instruction) to be used?
- TMF management issues: Trackers and logs are living documents during the entire life cycle of a clinical study, becoming final very often just at the closeout/end of a study. So, when is the right time to upload a tracker/log in the eTMF? When do you need to be ready in case of inspection?
- Lack of real-time access: Manual or semi-digital systems often fail to provide stakeholders with real-time visibility into trial progress, delaying decision-making. If a tracker is updated every six months, how can you ensure its reliability?
Why Use Trackers And Logs Despite The Challenges?
Despite these challenges, trackers and logs remain indispensable in clinical trials. Here’s why:
- Regulatory compliance: Trackers/logs such as the clinical regulatory submission tracker and SAE log help verify adherence to regulatory timelines and reporting requirements. Think about a clinical study performed in different countries, with different regulatory bodies, regulatory processes, and approval timelines. How can you have an overview of the overall regulatory situation in the different countries without a regulatory tracker/log?
- Audit/inspection readiness: Comprehensive logs like the NTF log and monitoring visit log prepare trial teams for audits and inspections by maintaining detailed and organized records. In preparation for an inspection, it’s important to know how many NTFs have been issued and where they are located. Also, due to the impact on data and patients, it’s crucial to be able to quickly verify all the monitoring visits that occurred as per the approved monitoring plan.
- Operational oversight: Tools like the protocol deviation log enable proactive identification and resolution of issues, minimizing risks to trial integrity.
- Data accuracy: Trackers reduce reliance on memory.
- Transparency: Shared trackers/logs can support stakeholders’ communication and data sharing when not everyone is working with the same systems and platforms.
- Holistic overview: Tools like an ICF tracker can provide faster, clearer, and more direct data related to the submission of the ICF (what version was submitted to what competent authority and when).
All the data contained in a tracker/log are coming from the documents collected in the study TMF. The point is that without a tracker/log you will have to open and read carefully each document and reconstruct the story. A tracker or log, if well developed, reconstruct the story for you.
Tips And Insights For Optimizing Tracker And Log Use
To maximize the value of trackers and logs while minimizing challenges, consider the following strategies:
- Digitize processes: Transition from manual to electronic trackers and logs to reduce errors and enhance efficiency. Many clinical trial management systems (CTMS) offer integrated solutions.
- Standardize formats: Develop standardized templates for commonly used trackers/logs to ensure consistency across studies.
- Centralized platforms: Use centralized platforms to consolidate tracker and log data, providing stakeholders with a single source of truth (e.g., eTMF).
- Regular training: Train site staff and trial teams on best practices for maintaining trackers and logs, emphasizing the importance of accurate and timely entries.
- Automate updates: Leverage automation to update trackers and logs in real time, reducing the administrative burden and enhancing visibility.
- Conduct periodic reviews: Regularly review trackers and logs to identify discrepancies or gaps, ensuring data integrity and compliance.
- Enhance security: Ensure that trackers and logs are password-protected to avoid data changes or manipulation.
The Future Of Trackers And Logs: A Digital Transformation
The transformation of trackers and logs into fully digital systems is not just a technological evolution — it’s a revolution in clinical trial management. Envision a future where data from every site, participant, and phase of a trial seamlessly flows into an integrated ecosystem, providing real-time insights to sponsors, CROs, and regulators alike. Such systems will not only automate routine tasks but, using artificial intelligence, will also predict potential issues, flagging risks before they materialize.
Digital systems promise to eliminate silos, reduce administrative burdens, and enhance compliance by automating routine tasks and providing intuitive interfaces for data entry and review.
This digital transformation will not happen overnight. It requires investment, collaboration, and a cultural shift toward embracing innovation. However, the potential benefits — increased efficiency, improved participant safety, and accelerated timelines — make this journey worthwhile. As trackers and logs evolve from static records to dynamic, intelligent tools, they will redefine what’s possible in clinical research, ensuring the industry remains adaptive and innovative in a rapidly changing world.
About The Author:
With 16 years of experience in the pharma industry, Donatella Ballerini first gained expertise at Chiesi Farmaceutici in the global clinical development department, focusing on clinical studies in rare disease and neonatology. Later, in global rare disease, Donatella served as a document and training manager, where she developed and implemented documentation management processes, leading the transition from paper to eTMF. In 2020, she became the Head of the GCP Compliance and Clinical Trial Administration Unit at Chiesi, ensuring all clinical operations processes complied with ICH-GCP standards and maintained inspection readiness. In 2021, she joined Montrium as the Head of eTMF Services, where she helps pharmaceutical companies in eTMF implementation and process improvement, and also works as an independent GCP consultant. Donatella has been a member of the CDISC TMF Reference Model Education Governance Committee since 2023 and the CDISC Risk White Paper Initiative since 2024.